Insight
FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions
by Georgia C. Ravitz, Shari Esfahani, Stephen Thau, Thora Johnson, Jeremy D. Sherer and Amy M. Joseph
2 minute read | January.13.2025

The FDA issued draft guidance on assessing AI model credibility for drug safety, effectiveness, and quality in regulatory decisions.